A Phase 2/3 interventional study of Pretomanid and Bedaquiline in Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant and Tuberculosis, MDR, sponsored by Global Alliance for TB Drug Development. Completed at 26 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by Global Alliance for TB Drug Development · Phase 2/3, Interventional, and Treatment
To evaluate the efficacy, safety and tolerability at 8 weeks (2-months), 52 weeks (12-months), and 104 Weeks (24-months) post the start of the following treatment regimens in participants with: Drug Sensitive TB (DS-TB) patients given BPaMZ for 17 Weeks ( or 4 months) vs. Standard HRZE/HR treatment given for 26 weeks (or 6 months) and Drug Resistant TB (DR-TB) patients given BPaMZ for 26 Weeks (or 6 months)
Phase 2c multi-center, open-label, partially randomized clinical trial in DS-TB and DR-TB participants.
All participants in the below arms will have follow-up for a period of 104 weeks (24 months) from the start of therapy.
Participants with Drug Sensitive TB (DS-TB):
Participants with DS-TB will be randomized to one of two treatment arms. These participants will receive either BPaMZ daily for 17 weeks (4 months), or HRZE/HR combination tablets daily for 26 weeks (6 months). participants will be stratified for co-infection with human immunodeficiency virus (HIV) and cavitation.
Participants with Drug Resistant TB (DR-TB):
Participants with DR-TB will be assigned to receive BPaMZ daily for 26 weeks (6 months).
319 studies on the registry are indexed under Tuberculosis, Pulmonary; 71 are open to participants now.
This study's enrollment of 455 is above the median of 146 across 227 interventional studies indexed under Tuberculosis, Pulmonary.
Browse Tuberculosis, Pulmonary studies →Global Alliance for TB Drug Development is the lead sponsor of 31 studies on the registry; 1 is open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 6 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
DS-TB treatment arm participants should be:
DR-TB treatment arm participants should be Resistant to rifampicin and/or isoniazid.
Exclusion Criteria:
Any of the following lab toxicities/abnormalities:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bedaquiline 200 mg daily for 8 weeks then 100 mg daily for 9 weeks, together with pretomanid 200 mg + moxifloxacin 400 mg + pyrazinamide 1500 mg daily for 17 weeks (Total treatment duration 4 months
Drug: Pretomanid · Drug: Bedaquiline · Drug: Moxifloxacin · Drug: Pyrazinamide
isoniazid 75 mg + rifampicin 150 mg + pyrazinamide 400 mg + ethambutol 275 mg (HRZE) combination tablets for 8 weeks AND isoniazid 75 mg + rifampicin 150 mg (HR) combination tablets for Weeks 9 to 26
Drug: HRZE · Drug: HR
Bedaquiline 200 mg daily for 8 weeks then 100 mg daily for 18 weeks, together with pretomanid 200 mg + moxifloxacin 400 mg + pyrazinamide 1500 mg daily for 26 weeks (Total treatment duration 6 months)
Drug: Pretomanid · Drug: Bedaquiline · Drug: Moxifloxacin · Drug: Pyrazinamide
200 mg tablets
Also known as: PA-824, Pa
100 mg tablets
Also known as: B, TMC207
400 mg tablets
Also known as: M
500 mg tablets
Also known as: Z
Drug pages: Isoniazid · Rifampin · Pyrazinamide · Ethambutol
isoniazid 75 mg plus rifampicin 150 mg plus pyrazinamide 400 mg plus ethambutol 275 mg combination tablets
Also known as: isoniazid, rifampicin, ethambutol
isoniazid 75 mg plus rifampicin 150 mg combination tablets
Also known as: isoniazid, rifampicin
Number of Participants With Culture Negative Status by 8 Weeks
Culture negative status is achieved when a participant produces at least two negative culture results at different visits (at least 7 days apart) without an intervening positive culture result for M.tb.
Time frame: Days 0-56 (8 weeks)
Number of Participants With Bacteriologic Failure or Relapse or Clinical Failure (Unfavorables) at 52 Weeks From Start of Therapy (12 Months)
Unfavorable status: 1. Participants not classified as having achieved or maintained culture negative status when last seen 2. Participants previously classified as having culture negative status who, following the end of treatment, have two positive cultures without an intervening negative culture 3. Participants who had a positive culture not followed by at least two negative cultures when last seen 4. Participants dying from any cause during treatment, except from violent or accidental cause, not including suicide 5. Participants definitely or possibly dying from TB related cause during the follow-up phase 6. Participants requiring an extension of their treatment beyond that permitted by the protocol a restart or a change of treatment for any reason except reinfection or pregnancy 7. Participants lost to follow up or withdrawn from the study before end of treatment
Time frame: 52 weeks after start of therapy
Time to Culture Negative Status
Culture conversion is a diagnostic criteria indicating the point at which samples taken from a patient infected with a tuberculosis can no longer produce tuberculosis cell cultures, that point is considered culture negativity
Time frame: During treatment (17 or 26 weeks)
| Milestone | Drug Sensitive-TB 4BPaMZ | Drug Sensitive-TB 2HRZE/4HR | Drug Resistant-TB 6BPaMZ |
|---|---|---|---|
| Started | 150 | 153 | 152 |
| Completed | 121 | 134 | 117 |
| Not completed | 29 | 19 | 35 |
Culture negative status is achieved when a participant produces at least two negative culture results at different visits (at least 7 days apart) without an intervening positive culture result for M.tb.
| Participants | Drug Sensitive-TB 2HRZE/4HR | Drug Sensitive-TB 4BPaMZ |
|---|---|---|
| Number of Participants With Culture Negative Status by 8 Weeks | 70 | 122 |
Unfavorable status: 1. Participants not classified as having achieved or maintained culture negative status when last seen 2. Participants previously classified as having culture negative status who, following the end of treatment, have two positive cultures without an intervening negative culture 3. Participants who had a positive culture not followed by at least two negative cultures when last seen 4. Participants dying from any cause during treatment, except from violent or accidental cause, not including suicide 5. Participants definitely or possibly dying from TB related cause during the follow-up phase 6. Participants requiring an extension of their treatment beyond that permitted by the protocol a restart or a change of treatment for any reason except reinfection or pregnancy 7. Participants lost to follow up or withdrawn from the study before end of treatment
| Participants | Drug Sensitive-TB 4BPaMZ | Drug Sensitive-TB 2HRZE/4HR | Drug Resistant-TB 6BPaMZ |
|---|---|---|---|
| Favorable | 120 | 134 | 111 |
| Unfavorable | 24 | 10 | 22 |
Culture conversion is a diagnostic criteria indicating the point at which samples taken from a patient infected with a tuberculosis can no longer produce tuberculosis cell cultures, that point is considered culture negativity
| weeks | Drug Sensitive-TB BPaMZ | Drug Sensitive-TB 2HRZE/4HR | Drug Resistant-TB BPaMZ |
|---|---|---|---|
| Time to Culture Negative Status | 6 (4 to 8) | 11 (6 to 12) | 5 (3 to 7) |
Collected over 28 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Drug Sensitive-TB BPaMZ | 3/150 (2%) | 17/150 (11.3%) | 139/150 (92.7%) |
| Drug Sensitive-TB 2HRZE/4HR | 2/153 (1.3%) | 7/153 (4.6%) | 144/153 (94.1%) |
| Drug Resistant-TB BPaMZ | 4/149 (2.7%) | 16/149 (10.7%) | 142/149 (95.3%) |
| Event | Drug Sensitive-TB BPaMZ | Drug Sensitive-TB 2HRZE/4HR | Drug Resistant-TB BPaMZ |
|---|---|---|---|
| HepatotoxicityHepatobiliary disorders | 8/150 | 1/153 | 4/149 |
| Transaminases IncreasedInvestigations | 1/150 | 0/153 | 3/149 |
| Hepatic Enzyme IncreasedInvestigations | 2/150 | 0/153 | 0/149 |
| TuberculosisInfections and infestations | 0/150 | 2/153 | 0/149 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 0/150 | 2/153 | 1/149 |
| AnaemiaBlood and lymphatic system disorders | 0/150 | 0/153 | 1/149 |
| Cholecystitis AcuteHepatobiliary disorders | 0/150 | 0/153 | 1/149 |
| Drug-Induced Liver InjuryHepatobiliary disorders | 0/150 | 0/153 | 1/149 |
| HypersensitivityImmune system disorders | 0/150 | 0/153 | 1/149 |
| COVID-19Infections and infestations | 0/150 | 0/153 | 1/149 |
| Event | Drug Sensitive-TB BPaMZ | Drug Sensitive-TB 2HRZE/4HR | Drug Resistant-TB BPaMZ |
|---|---|---|---|
| HyperuricaemiaMetabolism and nutrition disorders | 73/150 | 69/153 | 43/149 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 30/150 | 24/153 | 34/149 |
| HyperkalaemiaMetabolism and nutrition disorders | 23/150 | 25/153 | 3/149 |
| NauseaGastrointestinal disorders | 21/150 | 5/153 | 22/149 |
| HaemoptysisRespiratory, thoracic and mediastinal disorders | 4/150 | 14/153 | 19/149 |
| PruritusSkin and subcutaneous tissue disorders | 6/150 | 13/153 | 19/149 |
| DiarrhoeaGastrointestinal disorders | 11/150 | 5/153 | 18/149 |
| VomitingGastrointestinal disorders | 11/150 | 7/153 | 18/149 |
| DizzinessNervous system disorders | 7/150 | 4/153 | 18/149 |
| HeadacheNervous system disorders | 10/150 | 14/153 | 18/149 |
| Age, Continuous(years) | Drug Sensitive-TB 4BPaMZ | Drug Sensitive-TB 2HRZE/4HR | Drug Resistant-TB 6BPaMZ | Total |
|---|---|---|---|---|
| Mean | 36.4 (25.0 to 45.0) | 36.3 (26.0 to 46.0) | 37.6 (26.0 to 47.0) | 36.7 (26.0 to 46.0) |
| Sex: Female, Male(Participants) | Drug Sensitive-TB 4BPaMZ | Drug Sensitive-TB 2HRZE/4HR | Drug Resistant-TB 6BPaMZ | Total |
|---|---|---|---|---|
| Female | 38 | 35 | 58 | 131 |
| Male | 112 | 118 | 94 | 324 |
| Race (NIH/OMB)(Participants) | Drug Sensitive-TB 4BPaMZ | Drug Sensitive-TB 2HRZE/4HR | Drug Resistant-TB 6BPaMZ | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 8 | 3 | 13 | 24 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 108 | 119 | 82 | 309 |
| White | 29 | 25 | 31 | 85 |
| More than one race | 5 | 6 | 26 | 37 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Drug Sensitive-TB 4BPaMZ | Drug Sensitive-TB 2HRZE/4HR | Drug Resistant-TB 6BPaMZ | Total |
|---|---|---|---|---|
| Philippines | 6 | 2 | 9 | 17 |
| Tanzania | 52 | 48 | 7 | 107 |
| Brazil | 4 | 3 | 28 | 35 |
| South Africa | 56 | 68 | 72 | 196 |
| Uganda | 3 | 6 | 8 | 17 |
| Malaysia | 2 | 1 | 4 | 7 |
| Georgia | 23 | 20 | 9 | 52 |
| Russia | 4 | 5 | 15 | 24 |
| Height(cm) | Drug Sensitive-TB 4BPaMZ | Drug Sensitive-TB 2HRZE/4HR | Drug Resistant-TB 6BPaMZ | Total |
|---|---|---|---|---|
| Mean | 168.1 (163.0 to 175.0) | 168.9 (163.0 to 175.0) | 167.8 (162.0 to 175.0) | 168.3 (162.0 to 175.0) |
| Weight(kg) | Drug Sensitive-TB 4BPaMZ | Drug Sensitive-TB 2HRZE/4HR | Drug Resistant-TB 6BPaMZ | Total |
|---|---|---|---|---|
| Mean | 56.5 (48.8 to 62) | 55.6 (49.0 to 59.0) | 56.6 (48.3 to 63.6) | 56.3 (48.5 to 61.5) |
| BMI(Kg/m^2) | Drug Sensitive-TB 4BPaMZ | Drug Sensitive-TB 2HRZE/4HR | Drug Resistant-TB 6BPaMZ | Total |
|---|---|---|---|---|
| Mean | 20.0 (17.6 to 21.4) | 19.5 (17.2 to 20.4) | 20.1 (17.1 to 22.2) | 19.9 (17.3 to 21.2) |
| HIV Status(Participants) | Drug Sensitive-TB 4BPaMZ | Drug Sensitive-TB 2HRZE/4HR | Drug Resistant-TB 6BPaMZ | Total |
|---|---|---|---|---|
| Positive | 25 | 27 | 35 | 87 |
| Negative | 125 | 126 | 117 | 368 |
7 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — IPD from the trial will be submitted to Critical Path Institute which will make fully anonymized data available through the Tuberculosis Platform for Aggregation of Clinical TB Studies (TB-PACTS) database. Data sets for Drug susceptibility data, Demographic data, MTB diagnostic testing results, Concomitant medications information, Adverse event information, Treatment adherence information, Co-morbidities, Treatment outcomes, HIV co-infection information, CD4 counts, TB disease symptoms from all collected IPD will be made available.
Time frame: Data is expected to become available in mid-2024.
Access criteria: Researchers must agree to the Terms and Conditions for Use of the TB-PACTS data platform and submit an online application form to request access to the data platform.
Data sharing details ↗ · c-path.org
Ran from Jul 2018 to primary completion in Jul 2021, 35 months.
Results were first posted in Nov 2023, 2 years 4 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Pretomanid · Bedaquiline · Moxifloxacin · Pyrazinamide
Global Alliance for TB Drug Development